Engineer II, Utilities Engineer Small Molecule (Hopewell, NJ)

BeiGene•Hopewell, VA

2d•Onsite

About The Position

BeOne Medicines is seeking a highly motivated and organized engineer to join our team at the Hopewell, NJ site. The successful candidate will be responsible for supporting a new Small Molecule manufacturing facility and maintaining a stable, qualified, GMP manufacturing facility in close collaboration with the manufacturing and quality teams. The individual ensures reliable operation and state of compliance for a 24x7 commercial manufacturing facility. This role works independently, with minimal supervision and direction and will provide technical direction, Project Management support, Commissioning and SME expertise in the areas of utilities equipment supporting the small molecule drug product manufacturing facility and equipment. This role will be based in Hopewell NJ.

Requirements

BS or higher in engineering and/or related discipline.
Minimum of 4 + years of equipment and facility support in a GMP environment.
Strong understanding of Quality in GMP environment including Good Documentation Practices, Deviation, Change Control and CAPA management.
Strong knowledge of HVAC, Process Water, Chilled Water, Process Gases, Dust Collection and other utility equipment supporting small molecule drug product manufacturing facility.
Excellent communication and interpersonal skills, with the ability to collaborate across functional teams.
Proven ability to manage multiple complex priorities simultaneously under tight timelines.
Analytical problem-solving skills and proactive decision-making.
Ability to summarize and present project information clearly to management.
Bachelor’s degree in Engineering, Life Sciences, or related field with 4+ years of GMP pharmaceutical experience required, or Masters degree with 2+ years required.
People leadership, direct supervision required.
The ability to operate self-sufficiently and to motivate oneself is crucial for the success of this position.
In addition, the ability for this person to develop and maintain transparent communication between departments is essential.
Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word, Outlook).
Demonstrates strong accountability, communication, and ability to build trust in a fast-paced, regulated environment

Nice To Haves

Technical writing
OE and/or LEAN Methodologies
Proficiency with CMMS, Maximo preferred.
Experience with project management tools such as Microsoft Project, Autocad, Smartsheet.
Familiarity with data management and visualization tools (e.g., SharePoint, Teams, Power BI).
Ability to create and maintain Gantt charts, dashboards, and tracking templates.
Comfortable working within document management systems (e.g., Veeva Vault, eQMS, or similar).

Responsibilities

Provide SME input into Utilities and Facility for Small Molecule project.
Provide SME input for the commissioning, qualification and validation of responsible systems.
Start-up, troubleshoot and manage the clean and black utility equipment supporting the small molecule drug product manufacturing facility.
Develop and maintain technical, operational procedures, preventative maintenance plans for responsible systems.
Work in cross functional team with Global Engineering to hit project milestones and KPI’s.
Work with external partners as required.
Collaborate with the team members and develop positive relationships with all internal and external stakeholders.
Directly support manufacturing operations with respect to equipment, facilities, and utilities.
Requires working in an industrial manufacturing environment including gowning.
Other duties as assigned.